Cindy Mcclain Email & Phone Number

United States

• Oversee thirteen direct reports• Prepare and support internal/external audits• Complaint review for MDR reportability decisions• Approve MDRs for quality and required information for notified bodies• MDR drafting, publication, and submission• Complaint review for timely Investigation processing • Complaint review and closure within required timelines• Technical Support for electronic submissions gateway (ESG) and EMDR issues• Quality assurance across the product line• Complaint Document management• Ensure due diligence for complete complaint documentation i.e. DHRC, CAPA, Notifications, Regulatory evaluation, and Risk analysis• Responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions, which may include Non-Conformance Investigations, Field Actions, Documentation Management and Metrics. • Responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. • Communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.• Direct interface with Internal employees for reporting of complaints and adverse events. • Prepare for and attending MDR team meetings on behalf of the Complaint Handling Unit. • Provide guidance and direction; serves as expert and complaint handling process. • Prepare updates to FDA for Open Field Actions. • Prepare Weekly and Quarterly Complaint Handling Reports. • Processing and closing complaints, CAPAs and NCRs in a timely manner. • Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals.

Medtronic Navigation, Inc.

Monitors the Customer Loyalty Department’s activity to ensure timely complaint resolution and promotes customer satisfaction to meet or exceed departmental and regulatory requirements regarding product complaints. This individual has the responsibility and authority to facilitate cross-functional team review of customer complaints, analysis of root cause, complaint investigation, trending, and follow-up of corrective / preventive actions

Maintain and file safety reports submitted to the FDA.

Thousand Oaks, Ca

• Responsible for submitting marketed and investigational product information to the FDA, local and regional regulatory authorities, product investigators, and other internal groups and business partners.•• Serves as information liaison for nephrology, oncology, and inflammation. Receive all adverse events and distribute to appropriate manager; notify manufacturers of co-suspect relationships.•• Record case report submissions in central database.•• Perform pre-archive document quality control and maintain safety archives within FDA guidelines.• Maintain patient information and product information throughout lifecycle.•• Maintain regulatory and safety archives within FDA guidelines • Product Complaints• Handling of Recalls & Withdrawals• Procedures for Requesting Product Investigations Associated with Adverse Events• Product Complaint Trending & AE Reviews• Medical Device Reporting• Biological Product Deviation Tracking & Reporting• FDA Regulated Electronic Records and Signatures• Product Complaint Trending and AE Reviews• Labeling - Creation and Revision for Finished Commercial Products • Verification of Research Data Included in Submissions to Regulatory Authorities

Bachelor Of Science - Bs, Business Administration And Management, General

Associate Of Arts Degree, Mathematics